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Screening for Cardiovascular Disease Risk with Electrocardiography: an Evidence Review for the U.S

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Screening for Cardiovascular Disease Risk with Electrocardiography: an Evidence Review for the U.S Evidence Synthesis Number 163 Screening for Cardiovascular Disease Risk With Electrocardiography: An Evidence Review for the U.S. Preventive Services Task Force Pre pare d for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. HHSA-290-2015-00011-I, Task Orde r No. 5 Prepared by: RTI International–University of North Carolina at Chapel Hill Evidence-based Practice Center Research Triangle Park, NC Investigators: Daniel E. Jonas, MD, MPH Shivani Reddy, MD, MSc Jennifer Cook Middleton, PhD Colleen Barclay, MPH Joshua Green, BA Claire Baker Gary Asher, MD, MPH AHRQ Publication No. 17-05235-EF-1 June 2018 This report is based on research conducted by the RTI International–University of North Carolina at Chapel Hill Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA-290-2015- 00011-I, Task Order No. 5). The findings and conclusions in this document are those of the authors, who are responsible for its contents, and do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients). This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. None of the investigators has any affiliations or financial involvement that conflicts with the material presented in this report. Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project and deeply appreciate their considerable support, commitment, and contributions: Howard Tracer, MD, AHRQ Medical Officer, and Elisabeth Kato, MD, MRP, former AHRQ Medical Officer; Tracy Wolff, MD, MPH, AHRQ Associate Scientific Director; current and former members of the U.S. Preventive Services Task Force who contributed to topic deliberations; expert reviewers Joy Melnikow, MD, MPH, Amit Shah, MD, Fabrizio Turrini, MD, and Timothy Wilt, MD; federal partner reviewers at the National Institutes of Health; and RTI International–University of North Carolina EPC staff Carol Woodell, BSPH, Christiane Voisin, MSLS, Laurie Leadbetter, MSLS, Sharon Barrell, MA, and Loraine Monroe, publications specialist. Suggested Citation Jonas DE, Reddy S, Middleton JC, Barclay C, Green J, Baker C, Asher G. Screening for Cardiovascular Disease Risk With Electrocardiography: An Evidence Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 163. AHRQ Publication No. 17-05235- EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2018. Screening for CVD Ri sk Wi th ECG ii RTI–UNC EPC Structured Abstract Purpose: To systematically review the evidence on screening asymptomatic adults for cardiovascular disease (CVD) risk using resting or exercise electrocardiography (ECG) for populations and settings relevant to primary care in the United States. Data Sources: PubMed/MEDLINE, the Cochrane Library, and trial registries through May 30, 2017; reference lists of retrieved articles; outside experts; and reviewers, with surveillance of the literature through April 4, 2018. Study Selection: Two investigators selected English-language studies using a priori criteria. Eligible studies focused on the use of resting or exercise ECG for adults without symptoms or a diagnosis of CVD. Eligible designs included controlled trials comparing ECG screening with no ECG screening and prospective cohort studies reporting reclassification, calibration, or discriminat ion that compared risk assessment using ECG plus traditional risk factors versus traditional risk factors alone. For harms of ECG, prospective cohort studies, large retrospective cohort studies, and case-control studies were also eligible. For harms from exercise ECG or subsequent procedures/interventions, large registries or multicenter studies without a control group were also eligible. Data Extraction: One investigator extracted data and a second checked accuracy. Two reviewers independently rated quality for all included studies using predefined criteria. Data Synthesis: Sixteen studies (77,140 participants) were included. Two randomized, controlled trials (RCTs) (1,151 participants) found no significant improvement in all-cause mortality, cardiovascular-related mortality, myocardial infarction (MI), heart failure, or stroke for screening with exercise ECG in asymptomatic adults ages 50 to 75 years with diabetes compared with no screening. In addition, there was no significant improvement for their primary composite outcomes (hazard ratio [HR] 1.00 [95% confidence interval [CI], 0.59 to 1.71] for all- cause mortality, nonfatal MI, nonfatal stroke, or heart failure requiring hospitalization or emergency service intervention, and HR 0.85 [95% CI, 0.39 to 1.84] for nonfatal MI or cardiac death). No controlled trials evaluated screening with resting ECG. Although potential harms of exercise or resting ECG include arrhythmias, acute MI, sudden cardiac death, and harms of subsequent angiography or revascularization procedures after an abnormal test, evidence on their frequency in asymptomatic persons was scant. Evidence from five cohort studies (9,582 participants; mean baseline Framingham Risk Score [FRS] 10.8 to 12.3 in studies reporting it) shows that the addition of exercise ECG abnormalities to traditional CVD risk factors results in small improvements in discrimination (absolute improvement in area under the curve [AUC] or C-statistics 0.02 to 0.03; 95% CIs rarely reported), but it is uncertain whether calibration or appropriate risk classification improves. Evidence from nine cohort studies (66,407 participants; mean baseline risk ranging from low to high across studies) shows that the addition of resting ECG findings to traditional CVD risk factors results in very small or small improvements in discrimination (absolute improvement in AUC or C-statistics 0.001 to 0.05) and improvements for calibration and appropriate risk classification for prediction of multiple outcomes (e.g., all- cause mortality, CVD mortality, CHD events). Total net reclassification improvements (event; Screening for CVD Ri sk Wi th ECG iii RTI–UNC EPC nonevent) ranged from 3.6 percent (2.7%; 0.6%) to 30 percent (17%; 19%) for studies using Framingham Risk Score (FRS) or pooled cohort equations (PCE) base models (95% CIs were rarely reported). Limitations: The RCTs that evaluated exercise ECG in asymptomatic diabetic patients did not reach sample size targets and were stopped early because of trouble recruiting; both followed participants for about 3.5 years. For risk prediction with the addition of ECG, evidence was limited by imprecision, quality, and considerable heterogeneity. Consistency of findings for specific risk thresholds is unknown because all studies used different risk categories. About half of the included risk prediction studies did not use the published coefficients of externally validated base models such as FRS or PCE; only one used the PCE as a base model. For risk prediction with resting ECG, it is unclear what proportion of participants was truly asymptomatic because most studies did not report any assessment of symptoms. Conclusions: The overall strength of evidence was low or insufficient for each of the questions and outcomes evaluated. RCTs of screening with exercise ECG in asymptomatic participants found no improvement in health outcomes despite focusing on higher risk populations with diabetes. For asymptomatic persons without a history of CVD, the harms of exercise or resting ECG can include arrhythmias, acute MI, sudden cardiac death, and harms of subsequent angiography or revascularization procedures after an abnormal test, but the frequency of these harms is uncertain. Evidence on whether the addition of exercise ECG to traditional CVD risk factors results in accurate reclassification is lacking. Cohort studies found that the addition of multiple resting ECG abnormalities to traditional CVD risk factors accurately reclassifies persons, and improves discriminat ion and calibration, but evidence was limited by imprecision, quality, considerable heterogeneity, and inconsistent use of risk thresholds that align with clinical decisions and recommendations. Screening for CVD Ri sk Wi th ECG iv RTI–UNC EPC Table of Contents Chapter 1. Introduction......................................................................................................... 1 Scope and Purpose ............................................................................................................... 1 Condition Definition ...........................................................................................................
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